This presentation give information how important cleaning process in hospital to reduce cost stay in hospital and increase hospital revenue

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Global Medical Device Industry
310 billion US $ in 2010; 434 billion US $ in 2017
Pharma: 290 billion; 370 billion US $ in 2017
Annual growth rate 7%
MD industry is covering a wide spectrum of products
Life-time of the products is short and research and
development is high
New Areas including Tissue-Engineering products, Advanced
therapy medi cinical products and Combination products

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Differences between Medical Devices and Drugs
Medical Devices
• Physical objects: complex components
and assemblies; generally based on
mechanical and electrical features
• Most act through physical interaction with
body or body part
• Tend to require significant user interaction
• Heterogeneous group; range from
pflasters to artificial organs
• Duration and nature of exposure varies
widely
• Short market life (18-24 months) part
• Small and medium sized enterprizes (more
than 80%)
Drugs
• Pure molecules: based on pharmacology
and chemistry; now encompassing
biotechnology, genetic engineering etc.
• Administered via the mouth, skin, eyes,
lungs, or by injection; act through
metabolic, pharmacologic or
immunological means
• Generally little user interaction
• Tend to differ only in molecular structure
• Typically short half-life in body
• Long market life
• Generally little user interaction
Classification of Medical Devices

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Classification of medical devices
1) In accordance with: RKI, DGSV
2) The Regulations for Users of Medical Products refer to rules for preparation in §§ 2 and 4. It is clearly stated that preparation must be carried out in
accordance with the regulations of the “MPBetreibV”, the generally recognised technical regulations and the occupational safety and accident
prevention regulations (§ 2, Paragraph 1 “MPBetreibV”). Preparation may only be assigned to qualify personnel. (Source: Empfehlungen für die
Überwachung der Aufbereitung von Medizinprodukten (Projektgruppe RKI-BfArM-Empfehlungen 22.01.2008)

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Spaulding's Classification of Medical Devices and
Required Level of Processing/Reprocessing
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Operation, which have been cancelled due to not
sufficient reprocessed instruments
** 57/340 Datensätze
* mit freundl. Genehmigung G.Shapp MP

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Locations: Blood and Body Fluid Exposures
http://www.cdc.gov/nhsn/PDFs/NaSH/NaSH-Report-6-2011.pdf

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Personnel: Exposed to Blood and Body Fluids
http://www.cdc.gov/nhsn/PDFs/NaSH/NaSH-Report-6-2011.pdf(Source: CDC 2003)
Health Care Workers with Documented and
Possible Occupationally Acquired HIV/AIDS
CDC Database as of December 2002
* 3 dentists, 1 oral surgeon, 2 dental assistants
Documented Possible
Dental Worker 0 6 *
Nurse 24 35
Lab Tech, clinical 16 17
Physician, nonsurgical 6 12
Lab Tech, nonclinical 3 –
Other 8 69
Total 57 139

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BULLETS IN PLANES 2
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Challenges for surgical cleaners
15
"...in the absence of careful physical
cleaning, most disinfection and
sterilization processes are likely to be
ineffective. …only steam autoclaving
can overcome the barrier effects of
residual organic matter."
Source: Gastrointestinal Endoscopy
Vol 50 no. 2 1999, pg 288
 Removal of body tissue
soils like blood, mucous,
fats, and others
 Reduction of biofilms
Soiled patient care equipment (needles, syringes, surgical
instruments and other equipment) used for patient

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“Cleaning is always essential prior to disinfection or sterilization.
An item that has not been cleaned cannot be assuredly
disinfected or sterilized.”
Public Health Agency of Canada/Health Canada
Cleaning: The physical removal of foreign material (e.g., dust, soil) and organic
material (e.g., blood, secretions, excretions, microorganisms). Cleaning
physically removes rather than kills microorganisms. It is accomplished with
water, detergents and mechanical action. Cleaning must be performed before
high level disinfection or sterilization.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December2011
SOLUTIONS FOR MANAGEMENT AND QUALITY
ASSURANCE - TDOC
Basic Design of CSSD

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Steps in reprocessing critical medical equipment
AUTO WASHER
WORK TABLE
WELCOME
TO
DECONTAM

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WELCOME
TO
STERILE PROCESSING
READY
FOR
STERILIZATION

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COUNT SHEETS
OBSOLETE
EQUIP / INST
WORK AREA
Instructions for Cleaning, Sterilization ,Inspection and Maintenance of Osteosynthesis Medical Devices
Follow The Detailed Instructions step by step

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Verification of the Cleaning Process
So…What is CLEAN?
 Definitions from Guidelines and Standards:
- AAMI TIR 301: Removal of contamination from an item to the extent
necessary for further processing or the intended use.
- ASTM E23142: Removal of foreign materials, including organic soil (for
example, protein) and microorganisms from medical instruments.
- CDC Guideline 20083: Removal of visible soil (e.g., organic and inorganic
material) from objects and surfaces
See reference section for more info.
Verification of the Cleaning Process
The Recommendation
 ANSI/AAMI ST794 recommends:
- “Mechanical cleaning equipment should be tested upon
installation, weekly (preferably daily) during routine use, and
after major repairs”.

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PICTURE
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Reasons for cleaning
Blood fixation by sterilizing agents (glutaraldehyde, peracetic acid
Why cleaning of goods to be sterilized?
Removal of all visible dust and dirt, tissue, blood and foreign particles
Removal of breeding ground for surviving microorganisms
Reducing of the bioburden
Protection against corrosion
Ensure more safe free movement of equipment and materials
The Sterile Supply Cycle : Cleaning, Jan Huys 2004

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The Soil on used surgical instruments
• Soil contain protein
– When heating > ± 50°C  coagulation
• Is therefore is essential that :
– All these soils are removed before disinfection and
/ or sterilization
– The temperature of water
The bioburden
• By cleaning, the vast majority of
the bioburden is removed. Thus
Cleaning is considered the most
essential step in the sterile supply
cycle

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Proper cleaning is essential to reducing the risks associated with
improper or inadequate medical device reprocessing
Cleaning Reusable Medical Devices: A Critical First Step By Susan Shoemake, BA and Kathleen Stoessel, RN, BSN, MS
Cleaning Key points
Cleaning, disinfection, and sterilization are the backbone of infection
prevention and control.
Proper cleaning is essential before any disinfection
or sterilization process.
Failure to sterilize or disinfect
reusable medical devices properly
may spread infections.
IFIC Basic Concepts of Infection Control by Syed Sattar

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Cleaning of Used Instruments
The most important step in instrument reprocessing is cleaning
Studies have demonstrated that dirty instruments cannot be effectively
disinfected
Cleaning is the removal of visible soil (organic and inorganic material) from
instruments and is normally accomplished manually or automatically using
water and detergents with or without enzymes.
1. Alfa, et al. 1998 American Journal of Infection Control.
2. Rutala, 2008, CDC: “Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008”
Cleaning has three major objectives
Remove visible
soil
Remove invisible soil
Remove as
many harmful
microorganisms
as possible
Managing Infection Control by Stephen M. Kovach, BS, CSPDT, February 2007

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Residues on surgical instruments
NORMAL SURFACES
ARE NO
CLEANING PROBLEMS

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Cleaning problems
Technology Creates Cleaning Challenges

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COMPOSITION OF BLOOD

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Effect of the blood coagulation on cleaning
Cleaning comparison
defibrinated blood / coagulated blood
Cleaning Behaviour

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Residues after Cleaning
What are bloodborne pathogens?
• Bloodborne pathogens are microorganisms that can
cause disease when transmitted from an infected
individual to another individual through blood and
certain body fluids
• Causing serious illness and death
– Hepatitis B (HBV),
– Hepatitis C (HCV)
– Acquired immunodeficiency syndrome (AIDS) from HIV

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Brucellosis
Human
Immunodeficiency
Virus (HIV)
Include:
Hepatitis:
A, B, C, D, E
Execution
Types of Bloodborne Pathogens
Viruses or bacteria
that are carried in blood
and cause disease in
People.
Syphilis
Malaria
Transmission of BBPs
Bloodborne pathogens can
enter your body through:
 Contaminated instrument
injuries.
 A break in the skin (cut,
lesion, etc.).
 Mucus membranes (eyes,
nose, mouth).
 Other modes.

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Residue of blood or hemoglobin in medical instrument
From left to right: 100μg, 10μg, 1μg and 0.1μg of blood residues
Bloodborne pathogen strike-through
conversion chart
© 2003 Association for the Advancement of Medical Instrumentation ! ANSI/AAMI ST35:2003

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A few hours A few days

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The problem with biofilms
• Biofilms are ubiquitous in nature and cause a variety of
problems including:
– Fouling of membranes
– Biological fouling in medical instruments, oil field injection
wells, and cooling towers
– Infections and disease in people (e.g., contamination of
drinking water and dental unit water)
– Oral care/plaque buildup
– Corrosion of metal surfaces by sulfur-reducing bacteria (SRB’s)

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Polysaccharides produced by bacteria in biofilms
EPS Polymer Linkage Bacteria
Alginates b-1,4 mannuronic acid
a-1,4 guluronic acid
Pseudomonas
Amylopectin a-1,4 & a-1,6 glucose Ecoli
Celluloses b-1,4 glucose Acetobacter
Colanic Acids Glucose, galactose, fucose,
glucuronic acid, pyruvic acid
Salmonella, Ecoli
Dextrans a-1,6 & a-1,4 glucose Streptococcus, Acetobacter
Glycogen a-1,4 & a-1,6 glucose Bacillus, Pneumococci
Levans b-2,6 fructose Pseudomonas, Bacillus, Aerobacter
Polymannans b-1,4 mannose Desulfovibrio desulfuricans
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GET FASTERBLOOD
REMOVAL WITH
ENZYMATICDETERGENTS
Complete blood removal with proteases
NOVOZYMES PRESENTATION 545/14/2015
BLOOD IS THE MAIN AND MOST CRITICAL CONTAMINANT OF SURGICAL INSTRUMENTS AND IT IS USED IN
THE INTERNATIONAL STANDARD ISO15883 AS CHOSEN TEST SOIL (TOSI TEST) TO CHECK THE EFFICACY OF
CLEANING PROCEDURES FOR SURGICAL INSTRUMENTATION REPROCESSING
Timetakeninmin.toclean
Test stopped

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,
Multi-enzyme solution can help detergents
remove biofilm
THE SURGICAL
INSTRUMENTSWERE
SOAKEDFOR60 MIN AT
40°C
This data is based on
the removal of Model
Pseudomonas
auerginosa
biofilm, a common
microbe found on
surgical instruments
Unsoaked Soaked in
detergent
Soaked in
detergent +
multi-enzyme
solution
L* Values for Soaked Coupons Containing
Pseudomonas Auerginosa biofilm
12
14
16
18
20
Detergent+E2 Detergent+E1 Detergent only No Soaking
Treatment
L*
What are PRIONS?
Chobin. Infection Control Today. April 2008.

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Intrinsic Resistance
• Prions demonstrate resistance
to routine methods of
decontamination and
sterilization
• Prions are proteins, not
microorganisms
Comparative Frequency of Infectivity in Organs, Tissue, and Body Fluids of
Humans with Transmissible Spongiform Encephalopathies
(Creutzfeldt-Jakob Disease)
• Brain (including dura mater), spinal cord, posterior eye,
pituitary tissue
High
• Cerebrospinal fluid, liver, lymph node, kidney, lung, spleen,
placenta, olfactory epithelium
Low
• Peripheral nerve, intestine, bone marrow, whole blood,
leukocytes, serum, thyroid gland, adrenal gland, heart,
skeletal muscle, adipose tissue, gingiva, prostate, testis,
tears, saliva, sputum, urine, feces, semen, vaginal
secretions, milk, sweat
No Risk
infection control and hospital epidemiology february 2010, vol. 31, no. 2

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Relative Resistance of Different Microbial Types to
Microbial Control Agents
More resistant
Prions
Bacterial endospores
Mycobacterium
Staphylococcus and Pseudomonas
Protozoan cysts
Protozoan trophozoites
Most gram-negative bacteria
Fungi and fungal spores
Nonenveloped viruses
Most gram-positive bacteria
Less resistant
Enveloped viruses
Efficacy of Sterilization Processes in
Inactivating Prions
infection control and hospital epidemiology february 2010, vol. 31, no. 2

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Efficacy of Chemicals in Inactivating Prions
infection control and hospital epidemiology february 2010, vol. 31, no. 2
Instrument reprocessing – Deconex® 28 ALKA ONE-X destabilizes
the infectious prion protein
The infectious prion protein is proteinase K resistant. A treatment of the brain extract with phosphate buffer (6) (neg. control) or
with 0.5% deconex® 28 ALKA ONE-x + 0.15% deconex® TWIN ZYME at 55 °C (4) showed no effect on its proteinase K resistance.
In contrast, proteinase K was able to digest the prion protein after the brain extract had been treated with deconex® 28 ALKA ONE-x
at 0.5% / 70 °C (1) or 1.0% / 55 °C (2). When 1.0% deconex® 28 ALKA ONE-x together with 0.3% deconex® TWIN ZYME at 55 °C (3)
was used for treatment, the (destabilized) prion protein was degraded through the action of the proteases in deconex® TWIN ZYME
alone, without the additional action of proteinase K.
The treatment of the brain extract with potassium hydroxide at pH 12 (5) however showed less effect on the prion protein as a
residue of proteinase K resistant material on the Western Blot shows.

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TASS
Toxic anterior segment syndrome (TASS) is an
acute inflammation of the anterior chamber, or
segment, of the eye following cataract surgery
Toxic Anterior Segment Syndrome - TASS
• The Issue: serious damage to a patient’s
intraocular tissue and vision loss as a result
of contaminants in the eye during
ophthalmic surgery
• Causes: contaminated irrigating fluids;
antiseptics; antibiotic ointments; powder
from surgical gloves “Most cases of TASS
appear to result from inadequate instrument
cleaning and sterilization”
Nick Mamalis, MD, Toxic Anterior Segment Syndrome Journal of Cataract and Refractive Surgery 2006; 32:324-333

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Cause TASS
Bacterial
endotoxin
residues
Viscoelastic
residues
Exotoxins
Solutions and
Intra Ocular
Fluids
Preservatives Medication
Lenses / IOL Other Factors
Toxic Anterior Segment Syndrome - TASS
• Inadequate or inappropriate instrument cleaning
• “Detergents
• Heat stable endotoxin from overgrowth of gram-
negative bacilli in water baths or ultrasonic cleaners
• Degradation of brass containing surgical instruments
from plasma gas sterilization
• Impurities of autoclave steam”
Recommended practices for cleaning and sterilizing intraocular surgical instruments, J Cataract Refract Surg, Vol 33, June 2007

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AAMI ST79 2008 Amendments - Annex N (informative)
Toxic anterior segment syndrome (TASS) and the processing of surgical
instruments
 Follow Mfr’s. cleaning and sterilization instructions
 Adequate inventory-time for processing
 Designated cleaning area and dedicated equipment
• Precleaned immediately
• Transport in closed containers
• PPE
• Appropriate cleaning agent & water of appropriate
quality as specified by the Mfr.
• Sterilization according the Mfr’s. instructions
• Maintenance of cleaning and sterilization equipment,
boilers and water filtration systems
• Training
Known Contaminates
• Previous patient
• Water
Viable Microorganisms
• Previous patient
• Water
• Detergent
• Biofilm (washer or instruments)
Organic: Foreign Body
Contaminate (FBC)

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Different methods for cleaning of instruments

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The cleaning circle
Comparing the contributions of the factors involved in manual cleaning and machine cleaning
www.wfhss.com/html/educ/sbasics/sbasics0102_en.php
Copyright IAHCSMM 2007
Basic Instrument Cleaning Procedures

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Basic Components of Cleaning Solutions
Water
Detergent
SurfactantsBuffers
Chelating
agents
Enzymes
Cleaning Reusable Medical Devices: A Critical First Step By Susan Shoemake, BA and Kathleen Stoessel, RN, BSN, MS
Manual Cleaning of Used Instruments
www.henryschein.com/infectioncontrol

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Manual Cleaning
• “Lukewarm water-detergent solutions (at
temperatures optimally in the range of 27º C to 44ºC
[80º F to 110º F], but not to exceed 60º C [140º F])
will prevent coagulation and will thus assist in the
removal of protein substances. The temperature of
the soaking solution should be monitored and
documented.
• Devices should be thoroughly rinsed to remove
debris and detergent residues.(6.5.4.3.2)”
Working with your Automated Washer – Work Flow (Duties) TM

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Typical cleaning/disinfection process in an
automatic washer disinfector

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Simplified diagram for typical batch type
automatic washer disinfector

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Factors involved in Mechanical Cleaning
Detergent Chemistry :
• Chosen for the soil type
• Use optimal detergent
concentration
• Enzymes in the detergent
must be active
Temperature:
Too hot
• Blood coagulates and
becomes difficult to remove
• Enzymes may be inactivated
Too cold
• fats cannot be dissolved
• enzyme activity is decreased
Wash Time:
Too short
• Detergent does not have
enough time to remove soil
Mechanical Action:
• Involves water pressure,
spray arm rotation and
spray nozzle location

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Water and cleaning
• That it makes it so special :
– It is a good solvent for a large number of substances
– It has a relative high boiling point
– It is stable
– It has a very high surface tension
• Problems related to cleaning with water :
– Water prevents wetting of surfaces: surface tension
– Water cannot dissolve fats and oils
– Improving cleaning capability of water: Surfactants
(tensides)
www.wfhss.com/html/educ/sbasics/sbasics0102_en.php
www.wfhss.com/html/educ/sbasics/sbasics0102_en.php

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pH-value of Water
• Tap-water : 7,0 – 8,0
• Softened water: 7,5 – 8,5
• Softened water (warm) : 8,0 – 9,0
• DI-water : 5,5 – 6,5
Composition of water: water quality
www.wfhss.com/html/educ/sbasics/sbasics0102_en.php

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A surplus of H O (or what is the same the H ) causes acidity. A surplus of OH
causes a fluid to be basic. Acids typically add H cause and increase of acidity/thus
a lower Ph. Bases bring in OH ions and cause a fluid to basic, increasing the pH.
www.wfhss.com/html/educ/sbasics/sbasics0102_en.php
Effects of pH on Cleaning

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It all depends on the right type of water!
Variables that impact cleaning
• type of soil to be cleaned
Target soil
• item to be cleaned
Instrument design
• e.g., hardness,pH
Water quality
• A low temperatureat the start(to prevent denaturing) and higher
temperaturelater (to maximize enzymatic solution or detergent)Temperature and time
• The ability of the cleaning solution to hydrolyze targetsoils
Chemical activity
• the energy needed to clean (agitation)
Mechanical action
• e.g., stafftraining,loading methodsHuman variables and
intangibles

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Detergent: A synthetic cleansing agent that can emulsify
oil and suspend soil. A detergent contains surfactants
that do not precipitate in hard water and may also
contain protease enzymes (see Enzymatic Cleaner) and
whitening agents
Enzymatic Cleaner: A cleaning agent that contains
enzymes which break down proteins such as blood, body
fluids, secretions and excretions from surfaces and
equipment. Most enzymatic cleaners also contain a
detergent. Enzymatic cleaners are used to loosen and
dissolve organic substances
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
An ideal cleaning agent
is nonabrasive
is low-foaming
is free-rinsing
is biodegradable and environmentally friendly
provides for rapid soil dispersion or suspension
is nontoxic in the specified use dilution
is effective on clinically relevant soils under specified use conditions
has a long shelf life
is cost-effective
can be tested for effective concentration and/or use life
© 2011 Association for the Advancement of Medical Instrumentation AAMI TIR30:2011

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Reprocessing Decision Chart
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011 from the British Columbia (BC) Ministry of Health (the Ministry)
Most cleaning solutions for medical devices are composed of the following:
water, detergents,
surfactants, buffers, chelating agents, and one or more enzymes
Cleaning Reusable Medical Devices: A Critical First Step By Susan Shoemake, BA and Kathleen Stoessel, RN, BSN, MS

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What key professional organizations
say about enzymatic cleaners
“Neutral detergents/enzymes with a pH of 7, that are low foaming and free-rinsing
should be used for mechanical or manual cleaning of surgical instruments and
equipment …Neutral pH detergents work well used in combination with enzymatic
solutions as part of a cleaning regimen.” (PNDS: 170,175 AORN Association of
periOperative Registered Nurses 2008)
The following factors for the proper use of enzymatic product in their Central
Service Technical Manual-Seventh Edition:
1. Water temperature in the decontamination area
2. Room temperature in the decontamination area
3. Useful life and stability of the product being considered
4. Expiration date of product
5. The material used to constructthe device to be cleaned (material compatibility)
6. Whether the detergent (enzyme) is approved and registered with the
Environmental Protection Agency (EPA)
IAHCSMM (Association of Healthcare Central Services Materiel Management)
November 2008 • HEALTHCARE PURCHASING NEWS • www.hpnonline.com
What key professional organizations
say about enzymatic cleaners (cont)
Published new guidelines in 2008 for the use of enzymatic cleaners on
endoscopes in the GI Suites:
1. Medical grade, low foaming, neutral pH chemistry
2. Specially formulated bactericidal endoscope detergent designed
specifically to detach and destroy biofilm
3. An enzyme detergent designed for endoscopes
4. A detergent formulated to remove synthetic lipids
5. Free rinsing
(SGNA Society of Gastroenterology Nurses and Associates 2008)
An ideal cleaning agent would :
1. be nonabrasive
2. be low-foaming
3. be free-rinsing
4. be biodegradable
5. rapidly dissolve/dispersesoil
6. be nontoxic
7. be efficacious on all types of clinical soil
8. have a long shelf life
9. be cost-effective
(AAMI Association for the Advancement of Medical Instrumentation 2006)
November 2008 • HEALTHCARE PURCHASING NEWS • www.hpnonline.com

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Types of enzymes used in enzymatic
detergents
Enzyme Soil component Product
Proteases Proteins, oligopeptides, peptides Endopeptides and exopeptides
Lipases Acylglycerols Glycerol esters
Amylases Starch, glycogen α(1-4) and α(1-6) D-glucose
Cellulases Cellulose β(1-4) D-glucose
© 2011 Association for the Advancement of Medical Instrumentation AAMI TIR30:2011
Four basic types of enzymes are used to
clean surgical instruments
• breaks down
cellulosic materials
such as wood,
cotton and paper
• breaks down
carbohydrates and
starches
• breaks down
protein
• breaks down fats
and greases
Lipase Protease
CelluloseAmylase

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Characteristics and Clinical Benefits of
Enzymatic Detergents
Enzymatic Detergent: Biofilm removal
Vickery et al Am J Infect Control 2004;32:170-6.

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Formulation types of surgical cleaners
Neutral pH Detergent (pH 6 – 8) Alkaline pH Detergent (pH 10-12)
Enzymatic Detergent (~Neutral, pH 7-8)
• Single enzyme (e.g., protease or lipase)
• Multi-enzyme (protease, lipase, amylase,
cellulase…)
Selecting an Enzymatic Detergent
Water
temperatures in
the
decontamination
area
Room temperature
in the
decontamination
area
Useful life and
stability of the
product
Expiration date of
the product
The material used
to construct the
device to be
cleaned
Whether it is
approved and
registered by the
EPA

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The advantages and disadvantages of using
enzymes are directly related to their properties:
Module 2 – Enzyme Technology / BiologyMad.com
Characteristics of Enzymes?

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Enzymes and Temperature
• Temperatures above 400C (1400F) can affect
chemical reactions
• Cool temperatures may not activate the
enzyme
• Monitor water temperature and check
manufacturer instructions for specific
temperature requirements
Enzymes in Depth
• Enzymes are the biological substance
(proteins) that act as catalysts and help
complex reactions occur everywhere in life

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Enzymes in Depth
• Factors that affect the strength of an enzyme:
– pH
– Temperature
– Concentration of enzymes
– Concentration of Substrate
• Also a range of temperature in which it will work
– When the temperature drops/cools, activity of enzyme decreases/slows
down
– When temperature increases
1.Rate of reaction increases
2.Then decreases
3.Then stops (Denature)
– Most Biological Enzymes work in a temperature of 37°C
Temperature
• Temperature
– Each enzyme has an optimum temperature in which it works the best

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pH
• Most of biological enzymes work in a pH of 7, but there are some
exceptions (Pepsin and Trypsin)
• Enzymes are affected by pH and have an optimum pH
• If the pH goes above or beyond the range, the enzyme becomes
denatured
Effectiveness of Enzymatic Detergents

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Optimum Enzyme

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GET FASTERBLOOD
REMOVAL WITH
ENZYMATICDETERGENTS
Complete blood removal with proteases
BLOOD IS THE MAIN AND MOST CRITICAL CONTAMINANT OF SURGICAL INSTRUMENTS AND IT IS USED IN
THE INTERNATIONAL STANDARD ISO15883 AS CHOSEN TEST SOIL (TOSI TEST) TO CHECK THE EFFICACY OF
CLEANING PROCEDURES FOR SURGICAL INSTRUMENTATION REPROCESSING
Timetakeninmin.toclean
Test stopped
Protein fixation of High-Level Disinfectants

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Sterilization Categories
Medical Sterilization Methods – Mehul Patter
Sterilization Comparison Table
Medical Sterilization Methods – Mehul Patter

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Methods for disinfection and sterilization of patient-
care items and environmental surfaces
NOTE. Modified from [13],[14],and [17].AER, automated endoscope reprocessing;EPA, Environmental ProtectionAgency; ETO, ethylene oxide; FDA,
US Food and Drug Administration; GI,gastrointestinal;glut, glutaraldehyde; HP, hydrogen peroxide; PA, peraceticacid; OPA, ortho-phthalaldehyde.
a Consult FDA-clearedpackage inserts for information about FDA-clearedcontacttime and temperature; see text for discussion of why one product(2%
glut) is used at reduced exposure (20min at 20C).Increasingthe temperature by using AER will reduce the contacttime (e.g., for OPA, 12min at 20C,but
5 min at 25Cin AER). Tubing must be completely filled for high-level disinfection and liquid chemical sterilization. Compatibility of material should be investigated
when appropriate(e.g., HP and HP with PA will cause functionaldamage to endoscopes
HEALTHCARE EPIDEMIOLOGY • CID 2004:39 (1 September)
Cleaning and sterilization

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Cleaning and sterilization
nobelbiocare.com/sterilization
Characteristics of the main disinfectant groups
Hospital hygiene and infection control

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Common disinfectants used for
environmental cleaning in hospitals
Cleaning and High Level Disinfection of Medical
Equipment Steps

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Cleaning and High Level Disinfection of
Medical Equipment Steps
Steam sterilization with the autoclave

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Gas Sterilization
Ethylene oxide sterilization chamber
Alcohols
Dissolve membrane lipids,
denatures proteins.
Used for skin degerming.
Ethanol, Isopropanol
70% concentration -most
effective

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ANSI/AAMI ST79 Section 10 Quality Control
Routine load release Testing of each non-implant and implant load
Routine sterilizer
efficacy monitoring
Establishing a regular pattern of testing the efficacy of
the sterilization process
Sterilizer qualification
testing
Testing of the sterilizer after events occur which could
affect the ability of the sterilizer to perform
Periodic product
testing
Testing of routinely processed items to ensure the
effectiveness of the sterilization process and to avoid
wet packs
• Four levels of testing
What is a Cleaning Validation?
• Cleaning: Removal of soil residues.

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Validation Manual Cleaning
GUIDELINE FOR VALIDATION OF MANUAL CLEANING AND MANUAL CHEMICAL DISINFECTION MEDICAL DIVICES annex 9
Cleaning Validation Procedure
• Inoculate the device.
• Organic Soils
• Microorganisms
• Subject device to cleaning procedure.
• Usually with use of water and detergents.
• Extract remaining residues.
• Microbial, protein, hemoglobin, carbohydrate,
endotoxin

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Cleaning Monitors: Quality Program
• Ensure Staff competency for Manual
cleaning:
– initial training verification
– updated for new scopes/instruments
– yearly competency assessment
• Ensure ongoing adequacy of automated
washers & manual cleaning:
– monitor flexible endoscope lumens
– monitor cleaning of mechanical washers
Frequency of Monitoring??
• Quality Assurance Program:
ANSI/AAMI ST79 recommends
weekly (preferably daily)
monitoring of mechanical washer
cleaning efficacy
– Site implementation: -Establish site
baseline: initial daily testing of all
automated washers for a short
period of time-Ongoing each
washer tested minimally 1/week

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Cleaning Validation Acceptance Criteria
• Visually Clean
• Microorganisms – minimum of 3-log reduction
• Residual Limits Levels:
• Protein < 6.4µg
• Hemoglobin < 2.2µg
• Carbohydrate < 1.8µg
• Endotoxin < 2.2µg
Chemical indicators for checking cavitation

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amount of blood shown from left to right: 100μg, 10μg, 1μg, 0.1μg, Blind control
1. G. Schrader, G. Görisch : The Limitations of Instrument Cleaning Based on Data Collected on vCJD-Risks Posed by Medical Instrument. Hygiene & Medizin August 2003,
28. Jahrgang S. 306-309
2. Louise M. Edmunds, Andrew Rawlinson: The effect of cleaning on blood contamination in the dental surgery following periodontal procedures. Australian Dental Journal
1998; 43: (5):349-353

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Protein detection methods in manual cleaning
What does a FAIL result indicate?

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Clogged spray
nozzles
Cracked and leaking spray arm
What does a FAIL result indicate?
• Hard water can clog and damage pipes
and ultimately cause leaks.
• Calcium build-up in the washer could
immobilize spray arms.
• Debris from surgical instruments can
accumulate in the washer and eventually
end up in spray nozzles.

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What does a FAIL result indicate?
Chemical delivery problems
Crack in tubing
Plugged or kinked delivery
tubing or expired
detergents
Leaky pump tubing

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Quality control for cleaning
Visual inspection
Fluorescent powder and fluids with Ultra Violet light
Test Object Surgical Instruments (TOSI)
Test object for hollow instruments
Test object for flexible endoscopes
Protein Test
The Sterile Supply Cycle : Cleaning, Jan Huys 2004
Quality improvement program cycle

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